Competent authority
authority.competent-authority
National Agency for Food and Drug Administration and Control (NAFDAC)
NAFDAC · structured requirements
🇳🇬 Nigeria medical device regulatory data
Explore the medical device requirements currently available for Nigeria, organized by topic and linked to official sources.
5 facts5 dimensions3 official sourceslatest verification 2026-08-13
Legal basis & guidance
Which current law, regulation, guidance, and transition provisions apply?
Official legal and guidance surface
legal-basis.official-surface
- Authority
National Agency for Food and Drug Administration and Control (NAFDAC)
- SubmissionSurface
NAFDAC iRIMS stakeholder portal
- VerifiedHighlights
- NAFDAC publishes distinct imported and locally made medical-device registration guidelines.
- Its iRIMS portal supports application, tracking and registration management.
Official forms & portals
Which current form, portal, account, and submission package must be used?
Official form or portal surface
submission.official-form-or-portal-surface
- SubmissionSurface
NAFDAC iRIMS stakeholder portal
- VerifiedHighlights
- NAFDAC publishes distinct imported and locally made medical-device registration guidelines.
- Its iRIMS portal supports application, tracking and registration management.
Registration pathways
Which registration, notification, listing, reliance, or conformity route applies?
Market-access route or official registration surface
registration.market-access-route
- SubmissionSurface
NAFDAC iRIMS stakeholder portal
- VerifiedHighlights
- NAFDAC publishes distinct imported and locally made medical-device registration guidelines.
- Its iRIMS portal supports application, tracking and registration management.
Reliance & recognition
Which foreign decisions or evidence can be reused, with what effect and conditions?
WHO Prequalification of IVDs — collaborative abridged registration
reliance.reliance-edge-who-pq-ivd-to-crp43-program-who-pq-ivd-nigeria
- Target
geo:nga
- SourceApproval
WHO Prequalification of IVDs
- EdgeType
Collaborative Abridged Registration
- MarketAccessStrength
facilitated
- RegulatoryLayer
Product Marketing
- LocalApplicationRequired
Yes
- TargetDecisionRetained
Yes
- TimeTargetDays
90
- TimeBasis
Working Days After Access To All Relevant Information
Conditions
- WHO-prequalified IVDs
- manufacturer opt-in and consent
- participating NRA
- same product in all essential features
- national requirements and fees remain
Need to apply Nigeria's requirements to a product?
Confirm the current NAFDAC pathway, evidence, and local-role details for the actual device before filing.